MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC MX40 2.4 GHZ SMART HOPPING

Model Number 865351

Device Problems Defective Alarm (1014); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 09/30/2022

Event Type  Death  

Event Description

The customer is stating that monitor did not alarm as expected.The device as in use at time of event and the patient died.

Manufacturer Narrative

A follow up report will be submitted after philips obtains more information concerning this event.Reporting address state: (b)(6).Reporting institution phone: (b)(6).Reporter phone: (b)(6).

Event Description

The customer stated that on approximately on (b)(6) 2022, the mx40 did not alarm as expected and the patient was not able to be resuscitated and died.The clinical application specialist (cas) and field service engineer (fse) were consulted and determined that the logs were pulled but not analyzed as they were not requested by anyone initially.The cas did spend two days on site to review workflow and settings.All settings as expected and correct and the equipment behaved as expected.The customer was unable to provide further information to the fse or the cas on patient details or product information.Based on the onsite visit by the cas, the mx40 was behaving as expected and was not sent in for bench repair or had any further work done on it.The device per cas was working as expected, not a product malfunction.

Manufacturer Narrative

H10: updated h6 - to be able to perform proper trending.

• Brand Name: MX40 2.4 GHZ SMART HOPPING
• Type of Device: MX40 2.4 GHZ SMART HOPPING
• Manufacturer (Section D): PHILIPS NORTH AMERICA LLC; 3000 minuteman road; andover MA 01810
• Manufacturer (Section G): PHILIPS NORTH AMERICA LLC; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: jeanne ahearn ; 222 jacobs st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 15679348
• MDR Text Key: 302474553
• Report Number: 1218950-2022-00948
• Device Sequence Number: 1
• Product Code: DSI
• UDI-Device Identifier: 00884838082243
• UDI-Public: 00884838082243
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K113125
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 865351
• Device Catalogue Number: 865351
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Death